Mono-planar pedicle screw method, system and kit

ABSTRACT

A pedicle screw assembly ( 10 ) that includes a cannulated pedicle screw ( 20 ) having a scalloped shank ( 24 ), a swivel top head  30  having inclined female threads ( 44 ) in a left and right arm ( 34, 36 ) to prevent splaying, a set screw ( 50 ) having mating male threads  52 , a rod conforming washer ( 60 ) that is rotatably coupled to the set screw ( 50 ), the conforming washer including reduced ends to induce a coupled rod ( 80 ) to bend. A rod reduction system including an inner and an outer cannula ( 90, 100 ), the inner cannula ( 90 ) including a left and right arm ( 92, 94 ) that engage the swivel top head&#39;s ( 30 ) left and right arm ( 34, 36 ) and the outer cannula ( 100 ) dimensioned to securely slide over the inner cannula ( 90 ) to reduce the rod ( 80 ) into the swivel top head&#39;s ( 30 ) rod receiving area ( 38 ).

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a national stage application of and claims the benefit of PCT/US2006/016042 filed on Apr. 27, 2006, which claims the benefit of U.S. Provisional Patent Application No. 60/675,742, filed Apr. 27, 2005, and entitled “Uni-axial Pedicle Screw Construct with Set Screw and Percutaneous Rod Linkage Features Method, System, and Kit”. Both applications are incorporated by reference as part of the specification of this application.

BACKGROUND

1. Field of the Invention

The invention relates generally to orthopedic boney fixation systems and methods, and more particularly, to facet fixation systems and methods.

2. Description of Related Art

Some pedicle screw systems include a bone screw coupled to a rod receiving component or head. In these systems the screw may be moveable angularly relative to the rod receiving head prior to rod lock down. Such systems typically provide limited angular movement between the screw and rod receiving head. It is desirable to provide an easy to use and install pedicle screw system and a system that enables less limited angular movement between the screw and the rod receiving head. The present invention provides such a system and method.

SUMMARY OF THE INVENTION

The present invention includes a pedicle screw assembly (10) that includes a cannulated pedicle screw (20) having a scalloped shank (24), a swivel top head 30 having inclined female threads (44) in a left and right arm (34, 36) to prevent splaying, a set screw (50) having mating male threads 52, a rod conforming washer (60) that is rotatably coupled to the set screw (50), the conforming washer including reduced ends to induce a coupled rod (80) to bend. The present invention also includes a rod reduction system including an inner and an outer cannula (90, 100), the inner cannula (90) including a left and right arm (92, 94) that engage the swivel top head's (30) left and right arm (34, 36) and the outer cannula (100) dimensioned to securely slide over the inner cannula (90) to reduce the rod (80) into the swivel top head's (30) rod receiving area (38).

In an embodiment the screw shank includes a predetermined number of scallops where each scallop is shaped to engage a rod. In this embodiment the position of the swivel top head to the screw has a predetermined number of locations based on the number of scallops.

BRIEF DESCRIPTION OF THE DRAWINGS

The features, objects, and advantages of the present invention will become more apparent from the detailed description set forth below when taken in conjunction with the drawings in which like reference characters identify correspondingly throughout and wherein:

FIG. 1A is an isometric view of a pedicle screw assembly in accordance with the present invention.

FIG. 1B is an exploded, isometric view of the pedicle screw assembly shown in FIG. 1A.

FIG. 2A is a side view of the pedicle screw assembly shown hi FIG. 1A.

FIG. 2B is a sectional view of the pedicle screw assembly shown in FIG. 2A along line AA.

FIG. 2C is a top view of the pedicle screw assembly shown in FIG. 1A.

FIG. 3A is a front view of the pedicle screw assembly shown in FIG. 1A.

FIG. 3B is a sectional view of the pedicle screw assembly shown in FIG. 3A along line BB.

FIG. 4A is a partial section view of the pedicle screw assembly shown in FIG. 1A showing swivel head oriented 30 degrees offset from the longitudinal axis of the screw.

FIG. 4B is a partial section view of the pedicle screw assembly shown in FIG. 1A showing swivel head oriented 60 degrees offset from the longitudinal axis of the screw.

FIG. 5A is an isometric view of a pedicle screw according to an assembly embodiment of the present invention shown in FIG. 1A.

FIG. 5B is a side view of the pedicle screw shown in FIG. 5A.

FIG. 5C is a top view of the pedicle screw shown in FIG. 5A.

FIG. 5D is a sectional view of the pedicle screw shown in FIG. 5B along line AA.

FIG. 5E is a detailed view of the segment B of the sectional pedicle screw shown in FIG. 5D.

FIG. 6A is a side view of a swivel top head according to an assembly embodiment of the present invention shown in FIG. 1A.

FIG. 6B is a sectional view of the swivel top head shown in FIG. 6A along line AA.

FIG. 6C is a top view of the swivel top head shown in FIG. 6A.

FIG. 7A is a front view of a swivel top head according to an assembly embodiment of the present invention shown in FIG. 1A.

FIG. 7B is a sectional view of the swivel top head shown in FIG. 7A along line BB.

FIG. 7C is a sectional view of the detail area C of swivel top head shown in FIG. 7B.

FIG. 8A is a side view of a set screw according to an assembly embodiment of the present invention shown in FIG. 1A.

FIG. 8B is a sectional view of the set screw shown in FIG. 8A along line AA.

FIG. 8C is a sectional view of the detail area B of the set screw shown in FIG. 8B.

FIG. 8D is a partial, sectional view of the set screw shown in FIG. 8A.

FIG. 8E is a top view of the set screw shown in FIG. 8A.

FIG. 9A is an end view of a conforming washer according to an assembly embodiment of the present invention shown in FIG. 1A.

FIG. 9B is a sectional view of the conforming washer shown in FIG. 9A along line AA.

FIG. 9C is a bottom view of the conforming washer shown in FIG. 9A.

FIG. 10A is a side view of a stepped axel according to an assembly embodiment of the present invention shown in FIG. 1A.

FIG. 10B is an end view of the stepped axel shown in FIG. 10B.

FIG. 11A is a sectional view of a rod reduction system engaged to a swivel head of the assembly shown in FIG. 1A prior to reduction of the rod into the swivel head's rod receiving area.

FIG. 11B is another sectional view of the rod reduction system engaged to a swivel head shown in FIG. 1B after reduction of the rod into the swivel head's rod receiving area.

DETAILED DESCRIPTION

Throughout this description, embodiments and variations are described for the purpose of illustrating uses and implementations of the invention. The illustrative description should be understood as presenting examples of the invention, rather than as limiting the scope of the invention.

FIG. 1A is an isometric view of a pedicle screw assembly 10 in accordance with the present invention. FIG. 1B is an exploded, isometric view of the pedicle screw assembly 10 shown in FIG. 1A. The pedicle screw assembly 10 includes a pedicle screw 20, a swivel top head 30, a set screw 50, a conforming washer 60, and a stepped axel 70. The swivel top head 30 is coupled the screw 20 via the stepped axel 70. In one embodiment the conforming washer is rotatably coupled to the set screw 50.

FIG. 2A is a side view of the pedicle screw assembly 10 shown in FIG. 1A, FIG. 2B is a sectional view of the pedicle screw assembly 10 shown in FIG. 2A along line AA, and FIG. 2C is a top view of the pedicle screw assembly 10 shown in FIG. 1A. As shown in FIG. 2B, the pedicle screw 20 may be cannulated 22. In a process employing the pedicle screw 20, a guide wire (not shown) may first be securely placed in a pedicle. Then the pedicle screw assembly 10 without the set screw 50 and conforming washer 60 pair may be inserted over the guide wire to the pedicle via the cannulation 22. The screw 20 may then be advanced into the pedicle boney process and the guide wire removed from the pedicle bony process via the cannulation 22.

FIG. 3A is a front view of the pedicle screw assembly 10 shown in FIG. 1A and FIG. 3B is a sectional view of the pedicle screw assembly shown in FIG. 3A along line BB. As shown in FIG. 3B the stepped axel 70 extends through the pedicle screw 20 into the swivel top head 30. FIG. 3B also shows the conforming washing integrated within the set screw 50. As noted in one embodiment, the conforming washer 60 is rotatably integrated or coupled to the set screw 50.

FIG. 4A is a partial sectional view of the pedicle screw assembly 10 shown in FIG. 1A showing the swivel head 30 oriented 30 degrees offset from the longitudinal axis of the screw 20 along a single plane, mono-planar relative to the screw axis. FIG. 4B is a partial sectional view of the pedicle screw assembly 10 shown in FIG. 1A showing the swivel head 30 oriented 60 degrees offset from the longitudinal axis of the screw 20. As shown in FIGS. 4A and 4B, the pedicle screw 20 may have a scalloped shank 24 having a predetermined number of scallops. The scallops may have a concave shape to engage a rounded rod 80 (see FIG. 11A). In other embodiments the scallops may have different shapes as a function of the rod shape 80. After the screw 20 is advanced into a pedicle boney process a rod 80 may be inserted into the swivel head 30. Once the desired orientation between the screw 20 and swivel head 30 is achieved, the set screw 50 and conforming washer 60 may be inserted to compress the rod 80 against a scallop 24 of the screw 20 to maintain the desired orientation.

FIG. 5A is an isometric view of a pedicle screw 20 according to an assembly embodiment of the present invention shown in FIG. 1A. FIG. 5B is a side view of the pedicle screw 20 shown in FIG. 5 A. FIG. 5C is a top view of the pedicle screw 20 shown in FIG. 5A. FIG. 5D is a sectional view of the pedicle screw 20 shown in FIG. 5B along line AA. The pedicle screw 20 includes screw cannulation 22, plurality of scallops 24, threads, shank axel cannulation 28, and tip 29. As shown in FIG. 5B, the screw 20 tip 29 may be have a chamfer of about 60 degrees. In one process after a guide wire is securely inserted into a pedicle boney process a cannulated screw tap (not shown) may be inserted over the guide wire. The cannulated screw tap may then be used to create a tap within the pedicle boney process. The screw 20 includes the chamfered tip 29 to aid insertion into the tapped pedicle boney process, m one embodiment the screw 20 is inserted in a minimally invasive process so a practitioner may not be able to visual orient the screw within the formed pedicle tap.

FIGS. 5B, 5C, and 5D also include some dimensions. It is noted that the pedicle screw assembly 10 may work with screws 20 having different length and radii as a function of patient anatomy, in addition, the scallop dimensions and shape may vary as a function of the rod 80 to be employed with the pedicle screw assembly, in one embodiment the pedicle screw assembly consists primarily of titanium. FIG. 5E is a detailed view of the segment B (threads 26) of the sectional pedicle screw 20 shown in FIG. 5D. The thread pattern 26 is one embodiment in accordance with the present invention and the dimensions are also according to one embodiment in accordance with the present invention.

FIG. 6A is a side view of a swivel top head 30 according to an assembly embodiment of the present invention shown in FIG. 1A. FIG. 6B is a sectional view of the swivel top head 30 shown in FIG. 6A along line AA. FIG. 6C is a top view of the swivel top head 30 shown in FIG. 6A. The swivel top head 30 includes a head axel cannulation 32, left head arm 34, right head arm 36, head receiving channel 38, head rod seating area 42, female thread 44, and screw 20 shank receiving area 46. The left head arm 34 and right head arm 36 each include the female thread 44. FIGS. 6B and 6C include dimensions for one embodiment of a swivel top head 30 in accordance with the present invention.

FIG. 7A is a front view of a swivel top head 30 according to an assembly embodiment 10 of the present invention shown in FIG. 1A and FIG. 7B is a sectional view of the swivel top head 30 shown in FIG. 7A along line BB. FIGS. 7A and 7B include dimensions for one embodiment of a swivel top head 30 in accordance with the present invention. As shown in FIG. 7A the swivel top head 30 includes a head axel cannulation offset 48.

FIG. 7C is a sectional view of the detail area C of swivel top head 30 female thread 44 shown in FIG. 7B. The thread 44 includes a female thread lower rail 43 and a female thread upper rail. FIG. 7C includes dimensions for one embodiment of a female thread 44 for a swivel top head 30 in accordance with the present invention. As shown in FIG. 7C, the thread rails 43 and 45 are upwardly inclined. In a process where the set screw 50 is inserted into the left and right arms, the thread pattern 44 will prevent splaying of the arms 34 and 36.

FIG. 8A is a side view of a set screw 50 according to an assembly embodiment of the present invention shown in FIG. 1A. FIG. 8B is a sectional view of the set screw 50 shown in FIG. 8A along line AA. FIG. 8C is a sectional view of the detail area B of the set screw 50 shown in FIG. 8B. FIG. 8D is a partial, sectional view of the set screw 50 shown in FIG. 8A. FIG. 8E is a top view of the set screw 50 shown in FIG. 8A. FIGS. 8B and 8C include dimensions for one embodiment of a set screw 50 in accordance with the present invention. The set screw 50 includes a thread 52, conforming washer head receiving chamber 56, and set screw hexagonal key 58. The male thread 52 includes lower edge 51 and upper edge 54. The thread 52 is dimensioned to match with the female thread 44 to engage the arms 34 and 36 and prevent or limit splaying of the arms 34 and 36. The receiving chamber 56 may also include a receiving chamber edge 57.

FIG. 9A is an end view of a conforming washer 60 according to an assembly embodiment of the present invention shown in FIG. 1A. FIG. 9B is a sectional view of the conforming washer 60 shown in FIG. 9A along line AA. FIG. 9C is a bottom view of the conforming washer 60 shown in FIG. 9A. FIGS. 9A, 9B and 9C include dimensions for one embodiment of a conforming washer 60 in accordance with the present invention. The conforming washer 60 includes a washer head 62, washer head enlarged cap 63, rod conforming section 64, and rod conforming section reduced ends 65. The washer head 62 is dimensioned to be inserted into the washer head receiving chamber 56. The head enlarged cap 63 is dimensioned to prevent the conforming washer from being disengaged from the set screw 50 upon insertion into the set screw's receiving chamber 56 while enabling the set screw 50 to be rotated independently of the conforming washer 60.

In one embodiment the rod conforming section 64 includes reduced ends 65 that cause the conforming washer 60 bend a rod 80 when the set screw 50 compresses the conforming washer against the rod 80 (and screw shank scallops 24). In one embodiment the conforming washer 60 helps the rod 80 meet the natural lordosis of one or more vertebrae (not shown) that the rod 80 may be coupled thereto via the pedicle screw assembly 10.

FIG. 10A is a side view of a stepped axel 70 according to an assembly embodiment 10 of the present invention shown in FIG. 1A. FIG. 10B is an end view of the stepped axel 70 shown in FIG. 1B. FIG. 10A includes dimensions for one embodiment of a stepped axel 70 in accordance with the present invention. The stepped axel 70 includes an axel first section 72, an axel second section 74, an axel first section leading edge 76, and an axel second section edge 78. The stepped axel 70 is dimensioned to engage the swivel top head 30 shank receiving area while permitting the pedicle screw 20 to rotate freely thereabout via its shank axel cannulation 28.

FIG. 11A is a sectional view of a rod reduction system engaged to a swivel head 30 of the assembly 10 shown in FIG. 1A prior to reduction of the rod 80 into the swivel head's rod receiving area 38. The rod reduction system includes head engaging cannula 90 and reduction cannula 100. The head engaging cannula 90 includes first arm 94 and a second arm 96. In a process, the cannula 90 may be placed over the rod 80 after the swivel top head 30 with pedicle screw 20 is inserted in a pedicle boney process. The cannula 90's left and right arm 92 and 94 engage the swivel top head's 30 left and right arm 34 and 36. The cannula 90 is open between its arms 92 and 94. In a rod reduction process the cannula is advanced over the cannula 90 to engage the rod 80 and reduce the rod into the swivel top head's 30 rod receiving area 38. In the embodiment, the cannula is dimensioned to slide securely over the cannula 90. FIG. 11B is another sectional view of the rod reduction system where the cannula 90 is engaged to the swivel top head 30 and the rod has been reduced into the swivel top head 30 via the advancement of the cannula over the cannula 90.

While this invention has been described in terms of a best mode for achieving the objectives of the invention, it will be appreciated by those skilled in the wireless communications art that variations may be accomplished in view of these teachings without deviating from the spirit or scope of the present invention. 

1. A bone anchor assembly, comprising: a fixation element adapted to engage a bone, the fixation element having a shank portion and a head portion, the shank portion having an external thread form to engage bone, and the head portion adapted to articulate relative to a coupling element; an elongate axle; a coupling element having: (a) an internal bore extending along a longitudinal axis of the coupling element, the bore sized to mate with and articulate with the head portion of the fixation element, and (b) sidewalls comprising: (i) opposing upright projections forming a first channel having a first plane and adapted to receive a connecting rod, at least a portion of the opposing upright projections having locking features on an internal surface; and (ii) opposing downward projections each comprising an aperture, wherein the apertures are opposed and form a cannulation configured to receive the axle, and wherein the opposing downward projections form a second channel defining a second plane and adapted to receive the head of the fixation element therebetween, wherein the second plane is an articulation plane other than and not parallel to the first plane along which the long axis of the connecting rod courses; wherein the axle extends through the cannulation to retain the head portion of the fixation element in the second channel and permit articulation of the fixation element between the opposing downward projections of the coupling element along the second plane and prevents articulation of the fixation element along the first plane; and a compression element engagable with the locking features of the opposing upright projections, the compression element adapted to move distally within the coupling element to transmit a compression force on a connecting rod positioned through the first channel toward the head portion of the fixation element.
 2. The assembly of clam 1, wherein the head portion of the fixation element comprises at least one surface feature that mates with at least one outer surface feature of a connecting rod positioned through the first channel.
 3. The assembly of claim 2, wherein a plurality of mating surface features are disposed along the head portion of the fixation element, such that the at least one outer surface feature of the connecting rod interdigitates with the at least one surface feature of the head portion in each of the various positions of head articulation relative to the coupling element and connecting rod.
 4. The assembly of claim 2, wherein the head portion of the fixation element projects above the first channel such that the connecting rod positioned through the first channel contacts at least a portion of the fixation element upon rod reduction.
 5. The assembly of claim 2, further comprising a washer positioned above a connecting rod positioned through the first channel.
 6. The assembly of claim 5, wherein the washer has a mating surface that interdigitates with at least one surface feature of the connecting rod.
 7. The assembly of claim 6, wherein the connecting rod is sandwiched between the mating surface of the washer and the at least one surface feature of the fixation element, thereby locking the connecting rod, fixation element, and receiver element in relative position to each other.
 8. The assembly of claim 5, wherein the compression element comprises a chamber within which a proximal portion of the washer resides.
 9. The assembly of claim 8, wherein the proximal portion of the washer comprises a flange dimensioned to be inserted into the chamber of the compression element, the flange configured to prevent the washer from being disengaged from the compression element chamber.
 10. The assembly of claim 9, wherein the washer can rotate independent of and along the same axis of the compression element when rotatingly moved distally within the coupling element.
 11. The assembly of claim 1, wherein the opposing upright projections further comprise external channels configured for mating with a connecting rod reduction tool.
 12. The assembly of claim 11, wherein the external channels of the upright projections have undercut features that permit locking of the connecting rod reduction tool within the external channels.
 13. The assembly of claim 1, wherein the first plane is at a right angle to the second plane.
 14. A bone anchor assembly, comprising: a screw having a proximal head portion and a shaft extending from the proximal head portion, wherein at least a portion of the shaft includes a plurality of threads configured to couple to a first vertebra; a connecting element having a longitudinal axis, the connecting element configured to extend from the bone anchor assembly to a second bone anchor assembly coupled to an adjacent vertebra; and a receiving element comprising: an upper rod receiving section including a left and right arm forming a first channel for receiving the connecting element, the first channel having a first channel plane aligned with the longitudinal axis of the connecting element; and a lower screw receiving section including a first arm and a second arm forming a second channel sized to receive the proximal head portion of the screw and configured for articulation of the screw within the channel, the second channel having a second channel plane, wherein the second channel plane is offset from the first channel plane such that the screw articulates along the second channel plane and is prevented from articulating along the first channel plane.
 15. The assembly of claim 14, wherein the proximal head portion further comprises two approximately flat, opposing walls having an aperture running therethrough.
 16. The assembly of claim 15, wherein the assembly further comprises an axle that is configured to insert through the aperture of the proximal head portion and through opposing apertures through each of the first arm and second arm of the lower screw receiving section to rotatably couple the screw to the receiving element.
 17. The assembly of claim 14, wherein a plurality of surface features are disposed along a leading edge of the head portion, such that at least one surface feature of the head portion interdigitates with at least one external surface feature of the connecting element having a shape complementary to the at least one surface feature of the head portion.
 18. The assembly of claim 17, wherein the head portion projects above the first channel such that the connecting element positioned through the first channel contacts at least a portion of the head portion.
 19. The assembly of claim 17, wherein the left and right arms of the element receiving section each include an inclined female thread within the first channel.
 20. The assembly of claim 19, further comprising a set screw having male threads dimensioned to engage the first channel female threads.
 21. The assembly of claim 20, further comprising a washer positioned above a connecting element positioned through the first channel.
 22. The assembly of claim 21, wherein the washer has a mating surface that interdigitates with and has a shape complementary to the at least one external surface feature of the connecting element.
 23. The assembly of claim 22, wherein the connecting element is sandwiched between the mating surface of the washer and at least one of the plurality of mating surface features of the head portion, thereby locking the connecting element, head portion, and receiving element in relative position to each other.
 24. The assembly of claim 14, wherein the screw is prevented from articulating along the first channel plane receiver element both prior to and after compressed association of the connecting element with the proximal head portion of the screw.
 25. A fixation system for use in the spine, comprising: a first fixation element configured to couple to a first vertebra; a first receiver element coupled to the first fixation element and comprising a first channel configured to receive an elongated connecting element that extends from the first channel such that the course of the connecting element within the first channel defines a longitudinal axis of the first channel; a second fixation element configured to couple to a second vertebra; and a second receiver element coupled to the second fixation element and comprising a second channel configured to receive the elongated connecting element extending from the first receiver element, wherein the first and second receiver elements are configured to articulate relative to their respective fixation elements only along a plane that intersects and is non-parallel to a plane defined by the longitudinal axis.
 26. The fixation system of claim 25, wherein the first and second fixation elements are pedicle screws.
 27. The fixation system of claim 25, wherein the first and second receiver elements articulate relative to the first and second fixation elements by an articulating joint that is a hinge or a mortise joint.
 28. The fixation system of claim 25, wherein the connecting element comprises a connecting rod.
 29. The fixation system of claim 25, wherein the longitudinal axis defines the sagittal plane or parasagittal plane.
 30. The fixation system of claim 25, wherein the first and second receiver elements are configured to articulate relative to their respective fixation elements only along a plane that intersects and is non-parallel to a plane defined by the longitudinal axis both prior to and after compressed association of the first and second fixation elements with the connecting element. 